(26 days)
No
The document describes a mechanical ultrasonic scaler and does not mention any AI or ML capabilities.
Yes
Explanation: The device is intended for various dental and periodontal applications, including removing calculus, scaling, root planing, and preparing/cleaning root canals, all of which are therapeutic procedures to treat dental and periodontal conditions.
No
The device is an ultrasonic scaler used for various dental and periodontal procedures like removing calculus, scaling, root planing, and preparing/cleaning root canals. These are therapeutic and operative procedures, not diagnostic ones.
No
The device description explicitly lists hardware components such as the main scaler unit, peristaltic pump, hoses, handpieces, foot control, and bottles for irrigation liquids.
Based on the provided information, the EMS Piezon® Master 600 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes procedures performed directly on a patient's teeth and surrounding structures (supra and subgingival calculus removal, scaling, root planing, etc.). IVD devices are used to examine specimens (like blood, urine, tissue) taken from the body to provide information about a person's health.
- Device Description: The device description details a physical instrument used for mechanical procedures within the mouth. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing samples, reagents, or providing diagnostic information based on laboratory testing.
The EMS Piezon® Master 600 is a dental device used for therapeutic and preparatory procedures within the oral cavity.
N/A
Intended Use / Indications for Use
The EMS Piezon® Master 600 is an ultrasonic scaler intended for use in the following dental and periodontal applications:
- Removing supra and subgingival calculus deposits and stains from teeth .
- Periodontal pocket lavage with simultaneous ultrasonic tip movement .
- Scaling and root planing .
- Releasing crowns, bridges, inlays, and posts as well as condensing gutta ● percha
- Plugging for amalgam condensation .
- Amalgam burnishing ●
- Preparing, cleaning and irrigating root canals .
- Cavity preparation .
- . Cementing inlays and onlays
- Retrograde preparation of root canals ●
Product codes
ELC
Device Description
The proposed Piezon® Master 600 is a modification of the Piezon® Master 400. The modified Piezon® Master 600 consists of the main scaler unit (including a peristaltic pump for irrigant delivery), hoses and connectors for two handpieces, a foot control containing a four-position switch, and two bottles for holding irrigation liquids. The Piezon® Master 600 is supplied with one of a number of optional Instrument Systems (containing a Universal handpiece and scaling instruments), a flat key, and a torque tool (CombiTorque) for attaching instruments to the handpiece.
The overall design of the EMS Piezon® Master 600 is identical to the design of the unmodified Piezon® Master 400. The design modifications made to produce the EMS Piezon® Master 600 were implemented to improve the convenience and ease of use of the device and allow use of the Piezon® Master 600 with all instruments available for the EMS ultrasonic scaler product line. These design enhancements include the following:
- . Enhanced ultrasonic performance
- Improved handpiece appearance and ergonomics .
- . Irrigation liquid flow control moved to the handpiece hose
- Selection of dry and wet work functions moved to foot control .
- Addition of ultrasonic boost function to foot control ●
- Addition of three operating modes with different ultrasonic power ranges . selectable from main scaler unit
- Availability of three irrigation sources including two irrigation bottles and . external water supply
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The appropriate design verification and design validation activities were conducted to address the potential risks identified in the Hazard Analysis. These activities included electrical safety testing, electromagnetic compatibility testing, and the completion of Design Control Checklists to ensure that all design requirements were fulfilled. The results confirm that the modified EMS Piezon® Master 600 is safe and effective for the indicated dental and periodontal cleaning, preparatory, and restorative procedures.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.4850 Ultrasonic scaler.
(a)
Identification. An ultrasonic scaler is a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.(b)
Classification. Class II.
0
AUG 1 3 2002
Ko22328
Special 510(k): Device Modification 510(k) Summary for Electro Medical Systems SA EMS PIEZON® MASTER 600
1. SPONSOR
ELECTRO MEDICAL SYSTEMS SA Chemin de la Vuarpilliere 31 CH-1260 Nyon Switzerland
Contact Person: Suzanne Fassio Regulatory Manager
Date Prepared: July 17, 2002
2. Device Name
Trade/Proprietary Name: EMS Piezon® Master 600 Common/Usual Name: Ultrasonic Scaler Classification Name: Ultrasonic Scaler
3. Predicate Devices
1
INTENDED USE 4.
The EMS Piezon® Master 600 is an ultrasonic scaler intended for use in the following dental and periodontal applications:
- Removing supra and subgingival calculus deposits and stains from teeth .
- Periodontal pocket lavage with simultaneous ultrasonic tip movement .
- Scaling and root planing .
- Releasing crowns, bridges, inlays, and posts as well as condensing gutta ● percha
- Plugging for amalgam condensation .
- Amalgam burnishing ●
- Preparing, cleaning and irrigating root canals .
- Cavity preparation .
- . Cementing inlays and onlays
- Retrograde preparation of root canals ●
ഗ് DEVICE DESCRIPTION
The proposed Piezon® Master 600 is a modification of the Piezon® Master 400. The modified Piezon® Master 600 consists of the main scaler unit (including a peristaltic pump for irrigant delivery), hoses and connectors for two handpieces, a foot control containing a four-position switch, and two bottles for holding irrigation liquids. The Piezon® Master 600 is supplied with one of a number of optional Instrument Systems (containing a Universal handpiece and scaling instruments), a flat key, and a torque tool (CombiTorque) for attaching instruments to the handpiece.
6. BASIS FOR SUBSTANTIAL EQUIVALENCE
The modifications made to the parent Piezon® Master 400 to produce the proposed EMS Piezon® Master 600 were implemented to enhance the procedural flexibility and improve the ease of use of the device. These modifications do not alter the general intended use or fundamental scientific technology of the device.
Both the proposed and parent devices are ultrasonic scalers intended for use in dental and periodontal cleaning, preparatory, and restorative procedures. The capability of the Piezon® Master 600 ultrasonic scaler was enhanced to include the cavity preparation, cementation of inlays and onlays, and retrograde preparation of root canals. These applications were cleared for use with the EMS KERMIT®.
2
The overall design of the EMS Piezon® Master 600 is identical to the design of the unmodified Piezon® Master 400. The design modifications made to produce the EMS Piezon® Master 600 were implemented to improve the convenience and ease of use of the device and allow use of the Piezon® Master 600 with all instruments available for the EMS ultrasonic scaler product line. These design enhancements include the following:
- . Enhanced ultrasonic performance
- Improved handpiece appearance and ergonomics .
- . Irrigation liquid flow control moved to the handpiece hose
- Selection of dry and wet work functions moved to foot control .
- Addition of ultrasonic boost function to foot control ●
- Addition of three operating modes with different ultrasonic power ranges . selectable from main scaler unit
- Availability of three irrigation sources including two irrigation bottles and . external water supply
7. PERFORMANCE TESTING
The appropriate design verification and design validation activities were conducted to address the potential risks identified in the Hazard Analysis. These activities included electrical safety testing, electromagnetic compatibility testing, and the completion of Design Control Checklists to ensure that all design requirements were fulfilled. The results confirm that the modified EMS Piezon® Master 600 is safe and effective for the indicated dental and periodontal cleaning, preparatory, and restorative procedures.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 3 2002
Electro Medical Systems SA C/O Ms. Cynthia J. M. Nolte Medical Device Consultants, Incorporated 49 Plain Street North Attleboro, Massachusetts 02760
Re: K022328 Trade/Device Name: EMS Piezon® Master 600 Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: July 17, 2002 Received: July 18, 2002
Dear Ms. Nolte:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
4
Page 2 - Ms. Nolte
You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Patricia Cucinotta/Jr
Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if known):
Device Name: EMS Piezon® Master 600
Indications for Use:
The EMS Piezon® Master 600 is an ultrasonic scaler intended for use in the following dental and periodontal applications:
- Removing supra and subgingival calculus deposits and stains from teeth .
- . Periodontal pocket lavage with simultaneous ultrasonic tip movement
- . Scaling and root planing
- . Releasing crowns, bridges, inlays, and posts as well as condensing gutta percha
- . Plugging for amalgam condensation
- . Amalgam burnishing
- Preparing, cleaning and irrigating root canals ●
- Cavity preparation .
- Cementing inlays and onlays ●
- . Retrograde preparation of root canals
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Allie Goehner for MSR
nesthesiology, General Hospital. arting Control Dental I
510(k) Number: K022328
Prescription Use
(Per 21 CFR 801.109)
✓
OR
Over-The-Counter Use
(Optional Format 1-2-96)
July 17, 2002